Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction (GCQOL01)

A Pilot Randomized Controlled Trial Examining the Differences of Quality of Life of Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

The purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. To find a better reconstruction for patients who received total gastrectomy.

Study Overview

• Status: Unknown
• Conditions: Adenocarcinoma of Esophagogastric Junction.
• Intervention / Treatment: Other: Total Gastrectomy or Proximal Gastrectomy

Detailed Description

Overall, the incidence of stomach cancer worldwide is declining with geographical variation. However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or AEG has been observed in recent years. AEG may represent a specific histopathological and biologic entity. In the treatment AEG there is argument over whether proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL) of the patients following TG or PG arouses people's attention. The purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wang Ya Nong, MD, PhD; Phone Number: 1208 +86-21 64175590; Email: huahuang@fudan.edu.cn
• Study Contact Backup: Name: Huang Hua, MD,PhD; Phone Number: 1205 +86-21 64175590; Email: huahuang@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Ya Nong Wang, MD,PhD; Phone Number: 1208 +86-21 64175590; Email: huahuang@fudan.edu.cn
      • Contact: Hua Huang, MD,PhD; Phone Number: 1205 +86-21 64175590; Email: huahuang@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed at other institutions but slides must be confirmed at FUSCC, as is routine care at our institution), and the patients be assessed can achieve R0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists.

  • Patients 20-75 years old
  • Normal organ function, able to tolerate surgery, no clear contraindication for surgery
  • No evidence of metastases of adjacent organs
  • be able to provide follow-up over 2 years
  • No specific treatment for gastric cancer before surgery
  • In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
  • The subjects were able to understand and comply with the trial protocol, and signed informed consent.

Exclusion Criteria:

• • AEG SiewertⅠtype patients

  • Synchronous or metachronous (less than five years) and patients with other malignancies.
  • Cirrhosis and portal hypertension
  • Associated with blood diseases
  • Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
  • Suffering from a serious neurological disease or psychological diseases affecting the life.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Total Gastrectomy or Proximal Gastrectomy	Other: Total Gastrectomy or Proximal Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QOL (Quality of Life)	From preoperative following gastrectomy, as measured with the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-STO22 questionnaires.	5years

Secondary Outcome Measures

Outcome Measure	Time Frame
Nutritional status of patients	5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: September 29, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 2, 2012

Study Record Updates

• Last Update Posted (Estimate): October 2, 2012
• Last Update Submitted That Met QC Criteria: October 1, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Total Gastrectomy; Adenocarcinoma of Esophagogastric Junction; Proximal Gastrectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms
• Other Study ID Numbers: 2012-44-562